Clinical TrialMay 8, 2026, 04:32 PM
Vistagen Completes PALISADE-4 Phase 3 Trial; Results Expected Q2 2026
AI Summary
Vistagen Therapeutics announced the completion of the last patient visit in the randomized, double-blind, placebo-controlled portion of its PALISADE-4 Phase 3 clinical trial for fasedienol nasal spray, targeting acute social anxiety disorder. Topline results for this portion of the study are anticipated in the second quarter of 2026. The company also refined the statistical analysis plan for PALISADE-4, incorporating pre-dosing distress levels, a change the FDA had no comments on. This trial, if successful, along with previous positive results, could support a New Drug Application submission.
Key Highlights
- Last patient visit completed in randomized, double-blind, placebo-controlled portion of PALISADE-4 Phase 3 trial.
- PALISADE-4 evaluates fasedienol nasal spray for acute treatment of social anxiety disorder.
- Topline results for the randomized portion of PALISADE-4 are expected in Q2 2026.
- Statistical analysis plan (SAP) for PALISADE-4 was refined to include pre-dosing distress levels.
- FDA had no comments on the refined PALISADE-4 SAP.
- Fasedienol has FDA Fast Track designation for social anxiety disorder.
- Successful PALISADE-4 results could support a New Drug Application (NDA) submission.
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